HAMILTON-MR1 1610100

GUDID 07630002813556

Hamilton Medical AG

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 07630002813556
• NIH Device Record Key: 1dee9043-07d3-498e-94d7-701a00927e5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAMILTON-MR1
• Version Model Number: 1610100
• Catalog Number: 1610100
• Company DUNS: 481492312
• Company Name: Hamilton Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630002813556 [Primary]

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-03
• Device Publish Date: 2022-01-26

On-Brand Devices [HAMILTON-MR1]

• 07630002800761: 161010
• 07630002813556: 1610100